Gulisa Turashvili1, Joanne F Chou2, Edi Brogi1, Monica Morrow3, Maura Dickler4, Larry Norton4, Clifford Hudis4, Hannah Y Wen5. 1. Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. 2. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, New York, NY, 10017, USA. 3. Department of Surgery, Memorial Sloan Kettering Cancer Center, 300 E 66th Street, New York, NY, 10065, USA. 4. Department of Medicine, Memorial Sloan Kettering Cancer Center, 300 E 66th Street, New York, NY, 10065, USA. 5. Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. weny@mskcc.org.
Abstract
BACKGROUND/ PURPOSE: The 21-gene recurrence score (RS) assay evaluates the likelihood of distant recurrence and benefit of chemotherapy in lymph node-negative, estrogen receptor (ER)-positive, HER2-negative breast cancer patients. The RS categories are associated with the risk of locoregional recurrence (LRR) in some, but not all studies. METHODS: We reviewed the institutional database to identify consecutive female patients with node-negative, ER+/HER2- breast carcinoma tested for the 21-gene RS assay and treated at our center from 2008 to 2013. We collected data on clinicopathologic features, treatment, and outcome. Statistical analysis was performed using SAS version 9.4 or R version 3.3.2. RESULTS: Of 2326 patients, 60% (1394) were in the low RS group, 33.4% (777) in the intermediate RS group, and 6.6% (155) in the high RS group. Median follow-up was 53 months. A total of 44 LRRs were observed, with a cumulative incidence of 0.17% at 12 months and 1.6% at 48 months. The cumulative incidence of LRR at 48 months was 0.84%, 2.72% and 2.80% for low, intermediate, and high RS groups, respectively (p < 0.01). Univariate analysis showed that the risk of LRR was associated with the RS categories (p < 0.01), T stage (p < 0.01) and lymphovascular invasion (LVI) (p = 0.009). There was no difference in LRR rates by initial local treatment (total mastectomy vs. breast-conserving surgery plus radiation therapy). The RS remained significantly associated with LRR after adjusting for LVI and T stage. Compared to patients with low RS, the risk of LRR was increased more than 4-fold (hazard ratio: 4.61, 95% CI 1.90-11.19, p < 0.01), and 3-fold (hazard ratio: 2.81, 95% CI 1.41-5.56, p < 0.01) for high and intermediate risk categories, respectively. CONCLUSIONS: Our study confirms that RS is significantly associated with the risk of LRR in node-negative, ER+/HER2- breast cancer patients. Our findings suggest that in addition to its value for prognostic stage grouping and decision-making regarding adjuvant systemic therapy, the role of the RS in identifying patients not requiring radiotherapy should be studied.
BACKGROUND/ PURPOSE: The 21-gene recurrence score (RS) assay evaluates the likelihood of distant recurrence and benefit of chemotherapy in lymph node-negative, estrogen receptor (ER)-positive, HER2-negative breast cancerpatients. The RS categories are associated with the risk of locoregional recurrence (LRR) in some, but not all studies. METHODS: We reviewed the institutional database to identify consecutive female patients with node-negative, ER+/HER2- breast carcinoma tested for the 21-gene RS assay and treated at our center from 2008 to 2013. We collected data on clinicopathologic features, treatment, and outcome. Statistical analysis was performed using SAS version 9.4 or R version 3.3.2. RESULTS: Of 2326 patients, 60% (1394) were in the low RS group, 33.4% (777) in the intermediate RS group, and 6.6% (155) in the high RS group. Median follow-up was 53 months. A total of 44 LRRs were observed, with a cumulative incidence of 0.17% at 12 months and 1.6% at 48 months. The cumulative incidence of LRR at 48 months was 0.84%, 2.72% and 2.80% for low, intermediate, and high RS groups, respectively (p < 0.01). Univariate analysis showed that the risk of LRR was associated with the RS categories (p < 0.01), T stage (p < 0.01) and lymphovascular invasion (LVI) (p = 0.009). There was no difference in LRR rates by initial local treatment (total mastectomy vs. breast-conserving surgery plus radiation therapy). The RS remained significantly associated with LRR after adjusting for LVI and T stage. Compared to patients with low RS, the risk of LRR was increased more than 4-fold (hazard ratio: 4.61, 95% CI 1.90-11.19, p < 0.01), and 3-fold (hazard ratio: 2.81, 95% CI 1.41-5.56, p < 0.01) for high and intermediate risk categories, respectively. CONCLUSIONS: Our study confirms that RS is significantly associated with the risk of LRR in node-negative, ER+/HER2- breast cancerpatients. Our findings suggest that in addition to its value for prognostic stage grouping and decision-making regarding adjuvant systemic therapy, the role of the RS in identifying patients not requiring radiotherapy should be studied.
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